Prediction of Cmax [Dissolution / BCS / IVIVC]

posted by luvblooms  – India, 2008-07-22 08:43 (6543 d 21:55 ago) – Posting: # 2070
Views: 10,061

Dear Members :-)
Regards
This is my first post to this forum
We are working on a moleculae and in BE studies we found that
AUC0-t= 95 (83-109) AUC0-Inf= 91 (79-105) and Cmax= 105 (95-115). In this study using Level A IVIVC correlation we got the r2value of 0.976.
Now we want to have a new formulation in which we want to increase the AUC by higher initial release but now we are thinking that our Cmax can get affected too.
Is there any way to predict the Cmax of the next batch using IVIVC data (regression line equation) and Dissolution profile of proposed and existing batches.
Here are the datas

Mean Plasma Profile
Time   Reference   Test
 0.00      0.00      0.00
 1.00    182.52     48.47
 2.00    565.79    428.95
 3.00    809.47    682.06
 4.00   1005.12    929.53
 5.00   1434.22   1353.42
 6.00   1506.14   1571.97
 7.00   1549.33   1624.28
 8.00   1645.65   1712.17
 9.00   1681.64   1797.18
10.00   1703.32   1771.66
11.00   1645.02   1740.31
12.00   1603.28   1670.32
13.00   1525.32   1615.74
14.00   1537.53   1583.79
16.00   1359.26   1379.78
24.00    734.25    594.64
36.00    167.872   151.341
--------------------------


Dissolution profles
Time Ref  First (bio batch) Second (proposed)
 0     0          0              0
 1    11          6             17
 2    18         18             26
 4    30         36             42
 8    51         58             62
12    71         71             77
16    86         81             87
20    96         90             93
24   102         96             98
---------------------------------------------

Can we predict the Cmax for the proposed batch using the the above data...
Drug follows one CBM
Thanks in advance


Edit: reformatted using BBCodes (tabs may confuse some text-browsers). [Helmut]

~A happy Soul~

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